Adjunctive Stenting Research Articles

Abstract WP45: Subarachnoid Hemorrhage After Mechanical Thrombectomy With a Direct Aspiration First Pass Technique

Introduction: The incidence and clinical significance of subarachnoid hemorrhage post mechanical thrombectomy (MT) has been evaluated after stent retriever use in limited studies. The goal of this study is to report the incidence, identify predictors of SAH, and explore the effect of SAH on outcome after MT with ADAPT technique. Method: We interrogated our prospectively collected ADAPT database to identify patients who developed SAH post MT. All patients were treated using ADAPT technique. Collected variables included demographics, comorbidities, admission NIHSS, procedural variables and outcome variables. Post procedural CT scans were reviewed by independent Neuroneuro-surgeon to identify SAH. Successful recanalization was defined as mTICI≥ 2b. Outcome measures included 90 days modified Rankin scale (mRS) and mortality. Logistic regression was used to identify the predictors of SAH and explore the effect of SAH on outcome. Results: A total of 510 patients were included in the study. Thirty-three patients (6.4%) had evidence of SAH on the post thrombectomy CT scan. There were more patients with HTN in the SAH group (90.9% vs 73.2%; p=0.024). Adjunctive stent retriever was used more in SAH group (57.6% vs 29.6%; p=0.001). More patients in SAH group required two or more attempts to achieve recanalization (93.9% vs 62.8%; p<0.001). Successful recanalization was achieved in higher proportion of patients in the non-SAH group (93.5% vs 81.8% p=0.012). On multivariate analysis, only HTN (OR 0.29: 95% CI 0.086-0.983) and higher number of aspiration attempts (OR 6.124: 95% CI 1.32-28.25) were associated with SAH .With respect to functional outcome, patients with SAH had worse outcome (mRS 3-6) comparing to non SAH (75.8% vs 55.6%; p= 0.023). However, SAH did not predict poor functional outcome on multivariate analysis. Conclusion: SAH after mechanical thrombectomy is not uncommon. HTN and higher number of attempts were associated with SAH when ADAPT technique was used. The presence of SAH does not appear to predict worse outcome.

Mechanical Thrombectomy Using the Solitaire AB Device for Acute Embolic Mesenteric Ischemia

PurposeTo review preliminary efficacy and safety outcomes of mechanical thrombectomy using the Solitaire AB device combined with thromboaspiration for treatment of acute embolic occlusion of the superior mesenteric artery (SMA). Materials and MethodsBetween October 2015 and October 2017, 9 patients (average age, 77 y; range, 62–84 y) presenting with acute mesenteric ischemia attributable to embolic occlusion at the stem of the SMA were retrospectively evaluated for mechanical thrombectomy using the Solitaire AB device combined with manual thromboaspiration. Adjunctive stent implantation was performed to correct pre-existing atherosclerotic stenosis or as a rapid recanalization solution after unsuccessful thrombectomy. Technical success was defined as successful deployment of the Solitaire device across the thrombus and successful retrieval of the device. Clinical success was defined as successful embolus retrieval and SMA recanalization. Adjunctive procedures and periprocedural complications were noted. Technical success, clinical success, and follow-up outcomes were assessed. ResultsTechnical success was achieved in all patients. Clinical success was achieved in 7 (78%) patients. An adjunctive stent was required in 3 (33%) patients, including 1 unsuccessful thrombectomy. All patients had notable relief from abdominal pain after the procedure. No device-related complications or distal embolization events were noted during the procedures. Bowel resection was prevented in all patients. In-hospital mortality was 11% (1/9). During median follow-up of 6 months (range, 3–12 months), all surviving patients remained symptom-free, and stent patency was achieved in all patients. ConclusionsPreliminary outcomes suggest that mechanical thrombectomy using the Solitaire AB device with manual thromboaspiration is associated with rapid, effective, and safe recanalization for acute embolic occlusion at the stem of the SMA.

Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II.

DISRUPT PAD II was designed to evaluate the safety and performance of intravascular lithotripsy (IVL), a novel approach using pulsatile sonic pressure waves, to modify intimal and medial calcium in stenotic peripheral arteries. Vascular calcification restricts vessel expansion, increases the risk of vascular complications, and may impair the effect of anti-proliferative therapy. Disrupt PAD II was a non-randomized, multi-center study that enrolled 60 subjects with complex, calcified peripheral arterial stenosis at eight sites. Patients were treated with IVL and followed to 12-months. The primary safety endpoint was major adverse events (MAE) through 30 days. The primary effectiveness endpoint was patency at 12 months as adjudicated by duplex ultrasonography (DUS). Key secondary endpoints included acute procedure success, freedom from re-intervention, and functional outcomes. Between June 2015 and December 2015, subjects with moderate or severe calcified arterial lesions were enrolled. The final residual stenosis was 24.2%, with an average acute gain of 3.0 mm. The 30-day MAE rate was 1.7% with one grade D dissection that resolved following stent placement. Primary patency at 12 months was 54.5%, and clinically driven TLR at 12 months was 20.7%. Optimal IVL technique defined by correct balloon sizing and avoiding therapeutic miss, improved 12-month primary patency and TLR outcomes to 62.9% and 8.6%, respectively. IVL demonstrated compelling safety with minimal vessel injury, and minimal use of adjunctive stents in a complex, difficult to treat population.

Infrainguinal inflow assessment and endovenous stent placement in iliofemoral post-thrombotic obstructions

PurposeTo assess the technical success, patency, and clinical outcome, following assessment of inflow and infrainguinal endovenous stent placement in patients with iliofemoral post-thrombotic obstruction with infrainguinal involvement.MethodsA retrospective analysis of 39 patients with iliofemoral post-thrombotic venous obstruction accepted for infrainguinal stent placement in the period November 2009–December 2016. The clinical status was categorized according to the Clinical Etiological Anatomical Pathophysiological (CEAP) classification and symptom severity was assessed using Venous Clinical Severity Score (VCSS). The inflow was categorized as “good”, “fair”, or “poor” depending on vein caliber and extent of post-thrombotic changes in the inflow vessel(s). Stent patency was assessed by duplex ultrasound. Median follow-up was 44 months (range 2–90 months).ResultsStent placement was successful in all 39 patients. Primary patency after 24 months was 78%. Thirty of 39 patients (77%) had open stents at final follow-up. Re-interventions were performed in four patients and included catheter-directed thrombolysis (CDT) in all and adjunctive stenting in two. Twenty-eight of 39 patients (72%) reported a sustained clinical improvement. Patients with “good” inflow had better patency compared to those with “fair”/“poor” (p = 0.01). One patient experienced acute contralateral iliofemoral thrombosis; this segment was successfully treated with CDT and stenting. No other complications required intervention.ConclusionInfrainguinal endovenous stent placement was a feasible and safe treatment with good patency and clinical results, and should be considered in patients with substantial symptoms from post-thrombotic obstructions with infrainguinal involvement. Stents with good inflow have better patency and inflow assessment is essential in deciding the optimal stent landing zone.

Presentation and Management of Inferior Vena Cava Thrombosis

Inferior vena cava thrombosis (IVCT), although rare, has a potential for significant morbidity and mortality. IVCT is often a result of IVC filter thrombosis, but it can also occur de novo. Although anticoagulation remains the standard of care, endovascular techniques to restore IVC patency have become key adjunctive therapies in recent years. This study examines a single-center experience with diagnosis and management of IVCT. A retrospective Institutional Review Board-approved review of a single-center institutional database was screened to identify IVCT thrombosis using International Classification of Diseases code 453.2 over a 3-year period. Etiology of IVCT was separated into 2 groups: those with IVC thrombosis in the setting of prior IVC filter place and those in whom IVCT occurred de novo. Patient demographics, presenting characteristics, and management of IVCT were examined. Treatment options included expectant management with anticoagulation versus catheter-directed thrombolysis (CDT), mechanical thrombectomy, stenting, or a combination. For those who underwent intervention, technical success, defined as restoration of IVC patency, was assessed. Forty-one unique patients were identified with radiographically confirmed diagnosis of ICVT (mean age 61, range 25-91; 21 female, 51.2%). Eighteen (43.9%) patients presented with thrombosed IVC filter. Risk factors for venous thromboembolism included tobacco usage, current or prior smoking (n=17, 41.5%), history of prior deep vein thrombosis (n=25, 61.0%), malignancy (n=17, 41.5%), use of hormonal supplements (n=3, 7.3%), known thrombophilia (n=4, 9.8%), and obesity (body mass index: mean 29, range 18.8-58.53). Eleven patients (26.8%) presented with pulmonary embolism (PE), and of those 63.6% had IVC filter thrombosis (n=7). Risk of PE was not significantly different between those patients presenting with a thrombosed IVC filter compared to those with de novo IVCT (38.9% vs. 17.4%, P=0.12) Management of IVCT included anticoagulation alone (n=27, 65.9%), CDT (n=5, 12.2%), mechanical thrombolysis (n=10, 24.4%), and adjunctive IVC stent (n=3, 7.3%). Among the 14 (34.1%) patients who had intervention for IVCT, patency was restored in 12 patients (85.7%). IVCT is a rare event and is associated with known risk factors for venous thromboembolism. PE can occur in roughly 25% of patients presenting with IVCT. Presence of a filter does not appear to confer an advantage in preventing PE when IVCT occurs. Although majority of IVCT is managed with anticoagulation alone, endovascular interventions, including lysis and stenting, can safely restore patency in most properly selected patients.

Prolonged Versus Brief Balloon Inflation for Arterial Angioplasty

Angioplasty is a fundamental treatment of atherosclerotic disease; however, the optimal duration of balloon inflation has not been identified. Our study investigated whether prolonged inflation of at least 1 minute, compared with brief inflation, affects residual stenosis after arterial angioplasty. This study is registered on PROSPERO (92702). In compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, two independent reviewers conducted a systematic review of Embase, MEDLINE, Cochrane Central Register of Controlled Trials, trial registries, and gray literature. Data abstraction and quantitative analysis were performed independently, according to prespecified criteria. The primary outcome was residual stenosis after initial angioplasty in addition to other prespecific clinical and radiographic outcomes. Six relevant articles were identified, of which one investigated peripheral vascular angioplasty and five investigated coronary artery angioplasty, encompassing a total of 1496 procedures (Fig 1, A). The studies were at moderate risk of bias and displayed features of publication bias (Fig 1, B and C). Minimal heterogeneity allowed meta-analysis. Prolonged balloon inflation was significantly associated with lower risk of residual stenosis after inflation (risk ratio [RR], 1.78; 95% confidence interval [CI], 1.49-2.14; Fig 2, A and B) in addition to less than half the risk of arterial dissection and need for adjunctive procedures such as stenting (RR, 2.42 [95% CI, 1.73-3.38] and RR, 2.14 [95% CI, 1.54-2.96], respectively). Following adjunctive procedures, less residual stenosis was still observed in the prolonged angioplasty group (RR, 1.50; 95% CI, 1.08-2.07; Fig 2, C). Follow-up did not reveal a significant difference in the incidence of restenosis; however, there was a significant benefit of prolonged inflation in reducing severity of stenosis (mean difference, 3.18; 95% CI, 0.43-5.92; Fig 2, D and E). Sensitivity analysis accounting for the effect of vascular bed location or study design did not reveal significant differences. Prolonged angioplasty significantly improves immediate radiographic results; however, the long-term effect is less pronounced. Prolonged angioplasty is justified, particularly in situations in which adjunctive stent placement is avoided. This is the first review investigating the ideal duration of balloon inflation. Because peripheral interventions are not limited by symptomatic end-organ ischemia to the same degree as coronary interventions are, a clinical trial evaluating further prolongation of angioplasty inflation duration in small-caliber peripheral arteries is warranted.Fig 2Selected forest plots of meta-analyses. Articles are listed in increasing order of disparity in balloon inflation duration between treatment arms. A, Primary outcome: risk of residual stenosis immediately after initial angioplasty inflation. B, Severity of residual stenosis immediately after initial angioplasty inflation, measured as a continuous outcome of percentage stenosis. C, Risk of residual stenosis on index procedure completion angiography, following any adjunctive procedures. D, Risk of stenosis on follow-up angiography, at least 3 months after index procedure. E, Severity of stenosis on follow-up angiography performed at least 3 months after index procedure, measured as a continuous outcome of percentage stenosis. CI, Confidence interval; IV, inverse variance; SD, standard deviation.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Percutaneous coronary intervention: balloons, stents and scaffolds.

In this review, major achievements in the field of percutaneous coronary interventions are delineated with particular focus on Germany's contribution. The review deals with important developments, including the first heart catheterization and coronary angiography, first coronary balloon angioplasty and refinement of the technique, coronary stenting and optimization of adjunctive antithrombotic treatment, drug-eluting stents and balloons, as well as bioresorbable polymeric and metallic drug-eluting scaffolds.

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry.

With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.

IF08. Fate of the Unstented Superior Mesenteric Artery in Fenestrated Endovascular Aortic Aneurysm Repair

The objective of this study was to evaluate the patency of the unstented superior mesenteric artery (SMA) after fenestrated EVAR (F-EVAR) using duplex ultrasound (DUS) and computed tomography angiography (CTA). Patients with SMA fenestrations or crossing struts were identified from a database of patients who underwent F-EVAR at our institution between 2011 and 2017 as part of an investigational device exemption clinical trial (NCT01538056). Mesenteric DUS and CTA data were obtained at baseline and at 30 days, 6 months, and annually out to 5 years. The DUS parameter of SMA peak systolic velocity (PSV) of 275 cm/s was used to detect 70% SMA stenosis. CTA was used to evaluate the patency of the SMA when DUS PSV was elevated or if DUS was not performed. There were 107 patients who underwent endograft placement involving the SMA in association with F-EVAR. There were 87 SMA fenestrations and 20 bare-metal struts crossing the SMA; 79 patients had baseline and at least 30-day follow-up DUS SMA PSV measurements (64 fenestrations, 15 struts). Mean follow-up was 18.6 months (range, 30 days-5 years). SMA PSVs are listed in the Table. Mean PSVs remained well below the threshold velocity of 275 cm/s for native atherosclerotic 70% SMA stenosis. Nine patients had at least one SMA PSV >275 cm/s during follow-up. All were observed and showed no subsequent clinical sequelae. All patients had at least 30-day follow-up with CTA, and all had widely patent SMAs at last follow-up. Mean total seal zone length was 41.4 mm. There was a single secondary intervention for asymptomatic SMA stenosis requiring stent placement 1 year after F-EVAR. There were no Type IA endoleaks and no endoleaks related to SMA fenestrations. Five patients of the entire cohort (4.7%) required SMA stenting at the index procedure. Three of these patients had prior EVAR (n =2) or open repair (n = 1), One patient had a pre-existing critical SMA stenosis and underwent planned SMA stenting, and in one patient, the graft was deployed imprecisely and low, and the SMA was successfully stented from a brachial approach. The unstented SMA in association with F-EVAR remains widely patent in the presence of fenestrations or struts and is not associated with endoleaks. The need for adjunctive SMA stenting may be related to prior aortic intervention and case complexity. Follow-up DUS and CTA surveillance confirms that SMA patency remains in the normal or <70% stenosis range after F-EVAR regardless of whether it is encompassed by a large fenestration or crossing struts.TableSuperior mesenteric artery (SMA) peak systolic velocity (PSV)Fenestrations (n = 64)Struts (n = 15)Overall mean PSV (N = 79)Baseline128 ± 57153 ± 41133 ± 5530 Days115 ± 56155 ± 63123± 596 Months121 ± 80128 ± 82122 ± 801 Year131 ± 7799 ± 55124 ± 732 Years138 ± 89124 ± 58134 ± 813 Years145 ± 11399 ± 63129 ± 1004 Years134 ± 112120 ± 61129 ± 965 Years96 ± 61191 ±147122 ± 90Values are reported as mean ± standard deviation. Open table in a new tab

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions-a systematic review and meta-analysis.

Efficacy of drug-eluting balloons (DEB) for treatment of de novo coronary lesions remains controversial. The present systematic review and meta-analysis of randomised controlled trials assessed DEB with bare-metal stents (BMS) and also DEB with provisional bail-out stents ('DEB-only' strategy), to other conventional options: plain-old balloon angioplasty (POBA), BMS and drug-eluting stents (DES). A systematic literature search from January 2000 until May 2017 was conducted. Primary outcome measure, late lumen loss (LLL); and secondary outcomes; binary restenosis, major adverse cardiac events (MACE), target lesion revascularization (TLR), myocardial infarction (MI), cardiovascular death and stent thrombosis were analysed. Seventeen RCTs were included with 2,616 patients. Several comparative groups showed significant differences. DEB with BMS were inferior to DES for LLL [mean difference (MD) =0.12 mm; 95% confidence interval (CI), 0.03 to 0.22; P=0.01]; and binary restenosis [risk ratio (RR) =1.89; (CI, 1.13 to 3.18); P=0.02]. DEB with BMS was superior to BMS for LLL [MD =-0.27 mm; (-0.45 to -0.10); P=0.002]; and MACE [RR =0.64; (0.46 to 0.90); P=0.010]. Finally, DEB alone was superior to POBA for LLL [MD =-0.39 mm; (-0.67 to -0.11); P=0.006] and binary restenosis [RR =0.20; (0.05 to 0.85); P=0.03] in bifurcation lesions. The results of this meta-analysis showed that whilst DEB with BMS is superior to BMS alone, the combination is inferior to DES for treatment of de novo coronary lesions. Thus, DEB + BMS should not be applied in de novo lesions unless in patients who have absolute contraindications to DES. DEB alone, however, should be considered for relative contraindications to DES such as small vessel disease and bifurcation lesions.

Gore Iliac Branch Endoprosthesis for treatment of bilateral common iliac artery aneurysms

ObjectiveThe Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) has recently been approved by the Food and Drug Administration for treatment of common iliac artery (CIA) aneurysms. Despite early excellent results in clinical trial, none of 63 patients were treated for bilateral iliac aneurysms. The goal of this study was to examine real-world experience using the Gore IBE for bilateral CIA aneurysms. MethodsA retrospective review of an international multicenter (16 U.S., 8 European) experience using the Gore IBE to treat bilateral CIA aneurysms was performed. Cases were limited to those occurring after Food and Drug Administration approval (February 2016) in the United States and after CE mark approval (November 2013) in Europe. Demographics of the patients, presentation, anatomic characteristics, and procedural details were captured. ResultsThere were 47 patients (45 men; mean age, 68 years; range, 41-84 years) treated with bilateral Gore IBEs (27 U.S., 20 European). Six patients (12.7%) were symptomatic and 12 (25.5%) patients were treated primarily for CIA aneurysm (aorta <5.0 cm). Mean CIA diameter was 40.3 mm. Four patients had aneurysmal internal iliac arteries (IIAs). Two of these were sealed proximally at the IIA aneurysm neck and two required coil embolization of IIA branches to achieve seal in the largest first-order branches. Technical success was achieved in 46 patients (97.9%). No type I or type III endoleaks were noted. There was no significant perioperative morbidity or mortality. IIA branch adjunctive stenting was required in four patients (one IIA distal dissection, three kinks). On follow-up imaging available for 40 patients (85.1%; mean, 6.5 months; range, 1-36 months), 12 type II endoleaks (30%) and no type I or type III endoleaks were detected. Two of 80 (2.5%) IIA branches imaged were occluded; one was intentionally sacrificed perioperatively. ConclusionsPreservation of bilateral IIAs in repair of bilateral CIA aneurysms can be performed safely with excellent technical success and short-term patency rates using the Gore IBE device. Limb and branch occlusions are rare, usually are due to kinking, and can almost always be treated successfully with stenting.

USE OF DRUG-ELUTING STENTS VERSUS STANDARD NITINOL STENTS AFTER DRUG-COATED BALLOON ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY: INSIGHTS FROM THE MULTICENTER EXCELLENCE IN PERIPHERAL ARTERY DISEASE (XLPAD) REGISTRY

Paclitaxel drug-coated balloon (DCB) angioplasty in superficial femoral artery (SFA) interventions has steadily increased since its introduction in 2014. After SFA angioplasty, adjunctive stenting with drug-eluting (DES) or nitinol stents can be used to treat residual dissection or recoil. There is

Treatment of Femoral Vein Obstruction Concomitant with Iliofemoral Stenting in Patients with Severe Post-thrombotic Syndrome

The aim was to assess the clinical and anatomical outcomes of iliofemoral stenting, with concomitant femoral stenting or balloon angioplasty alone, in patients with severe post-thrombotic syndrome (PTS) and compromised inflow. A database of patients with severe PTS who successfully underwent endovascular iliofemoral stenting was reviewed retrospectively. Patients with impaired inflow with chronic post-thrombotic obstructive lesions in the femoral vein (FV), but patent profunda vein, were selected and divided into two groups: the FV stenting (FV-S) group and the FV angioplasty (FV-A) group. Patients in the FV-S group were treated with concomitant iliofemoral and FV stenting, and patients in the FV-A group were treated with iliofemoral stenting and balloon angioplasty alone of the obstructed femoral vein. The clinical and stent outcomes were recorded and compared in the two groups. There were 45 patients in the FV-S group and 69 patients in the FV-A group. The groups were well matched for age, gender, and diseased limbs. The pre-procedural symptoms, CEAP classifications, VCSS scores, Villalta scores, and prevalence of active ulcers were also similar between the two groups. Immediate failure (<30 days post-procedure) in the femoral segment occurred more frequently in the FV-A group (70% in FV-A group vs. 24% in FV-S group, p<.001); however, all treated femoral vein segments had occluded at 12 months. There was no significant difference between the FV-S and FV-A groups in cumulative primary and secondary patency rates of the iliofemoral stent at 3 years (55% vs. 52%, p=.71, and 77% vs. 85%, p=.32, respectively). Complete pain relief, swelling relief, VCSS score, Villalta score, and freedom from ulcers at a median of 22 months (1-48 months) following the procedure were similar in the two groups. Stent placement to treat post-thrombotic iliofemoral obstruction with concomitant obstructed femoral vein but patent profunda vein shows cumulative patency rates and clinical outcomes similar to previous reports. Adjunctive femoral stenting or angioplasty of the obstructed femoral vein does not appear to improve clinical or stent outcomes in patients with severe PTS.

Jetstream Atherectomy System treatment of femoropopliteal arteries: Results of the post-market JET Registry.

To report on procedural, safety, and effectiveness outcomes of real-world practice with the Jetstream rotational atherectomy system for treatment of femoropopliteal artery lesions. Safety and effectiveness of treatment with the Jetstream device has been demonstrated in clinical trials, but outcomes during real-world clinical practice have yet to be examined. 241 patients (66% male, mean age 67years, 41% diabetes; Rutherford 1-3) with de novo or restenotic (non-stent) femoropopliteal lesions ≥4cm in length were recruited. Major adverse events (MAE), defined as amputation, death, target lesion/vessel revascularization (TLR/TVR), myocardial infarction, or angiographic distal embolization that required a separate intervention; and binary restenosis were assessed at 30days and 12months. The mean (±SD) lesion length was 16.4±13.6cm; 35% of patients received adjunctive stents. Procedural success was achieved for 98.3% of lesions. The 30-day MAE rate was 2% (5/219; 2 TLR/TVR and 3 distal embolization); there were no deaths, index limb amputations, or myocardial infarctions. At 12months, the overall estimated freedom from TLR/TVR was 81.7% and 77.2% (44/57) of patients were free from duplex ultrasound-assessed restenosis. Efficacy and patency in a diabetic subset were similar to those of the overall cohort, while maintaining a similar safety profile. In a cohort reflecting real-world practice, the Jetstream Atherectomy System demonstrated a high procedural success rate with a low rate of complications and reinterventions, especially given the relatively long lesions studied.

Outcomes at a single center after subintimal arterial flossing with antegrade-retrograde intervention for critical limb ischemia

ObjectiveThe subintimal arterial flossing with antegrade-retrograde intervention technique has been used to overcome antegrade recanalization failures for peripheral lower limb arterial occlusive disease. There are few outcomes published for this technique and we sought to evaluate outcomes at our institution over a 7-year period. MethodsA retrospective review was performed of all subintimal arterial flossing with antegrade-retrograde intervention procedures of infrainguinal occlusive disease from 2009 to 2016. Retrograde and antegrade accesses were combined when occlusions could not be crossed from the antegrade direction. Baseline patient characteristics, procedures, procedure time, fluoroscopy time, contrast used, and radiation dose were collected. Posterior tibial waveforms, ankle-brachial index, limb salvage, vessel patency, and the presence of symptoms were assessed at follow-up. ResultsTreatment was performed in 52 limbs in 52 patients (35 men and 17 women; mean age, 77.62 ± 11.61 years) with critical limb ischemia and no appropriate venous conduit for surgical bypass. Among the cohort, 63.5% were diabetics, 98% had hypertension, 53.8% had a prior myocardial infarction, and 36.5% end-stage renal disease. The average Rutherford Category before the intervention was 5.08 ± 1.01. Retrograde pedal access was most commonly obtained in the anterior tibial artery/dorsalis pedis (55.7%), followed by the posterior tibial artery (40.3%). The technical success rate was 63.5% (33/52); adjunctive stenting was needed in 19 (36.5%) to optimize results. Preprocedural ankle-brachial index score was 0.54 ± 0.25, which improved after the procedure to an ankle-brachial index score of 0.77 ± 0.25. The primary patency rates at 3 and 6 months were 65% and 60%, respectively. The limb salvage rate at a mean follow-up of 5.4 months was 78.8%. There were 5 complications; 4 were hematomas managed conservatively and 1 was a major retroperitoneal bleed resulting in patient death. ConclusionsRetrograde pedal access is a viable revascularization technique for achieving limb salvage in patients with critical limb ischemia with acceptable patency for limb-threatening ischemia. This technique expands revascularization options after failed conventional endovascular antegrade approaches.

One-Year Outcomes Following Directional Atherectomy of Popliteal Artery Lesions: Subgroup Analysis of the Prospective, Multicenter DEFINITIVE LE Trial

Purpose: To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease. Methods: This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound–defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed. Results: Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline. Conclusion: This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients.

TCT-25 Insights Into The Mechanisms of Action of The Rotational Atherectomy: An Oct Study

The aim of our study is to characterize, using OCT, the morphologic features of calcific plaques after rotational atherectomy, adjunctive balloon angioplasty and stenting. A total of 57 consecutive patients who had undergone angioplasty using rotational atherectomy were included. The 67 lesions

Results of AFX Unibody Stent-Graft Implantation in Patients With TASC D Aortoiliac Lesions and Coexistent Abdominal Aortic Aneurysms

Purpose: To describe results of AFX unibody stent-graft treatment for TransAtlantic Inter-Society Consensus (TASC) D aortoiliac occlusive disease (AIOD) with coexistent abdominal aortic aneurysm (AAA). Methods: A retrospective analysis was conducted of 21 consecutive patients (mean age 73.6±6.4 years; 17 men) with TASC D AIOD plus AAA (diameter >3.5 cm) treated electively using the AFX stent-graft. Common iliac artery (CIA) and external iliac artery (EIA) stenosis or occlusion was reported. Outcome measures were technical and clinical success, improvement in ankle-brachial index (ABI), and improvement in Rutherford category. Immediate and midterm patency, AAA exclusion, major adverse events (MAE), and mortality were also evaluated. Results: After AFX deployment (100% technical success), 18 EIAs required adjunctive stenting (none required in the CIA). One patient required a reintervention for closure device failure. At 30-day follow-up, no death or MAE was recorded. Improvement in ABI was registered in all patients (mean 0.91±0.11), with 100% primary patency. At a mean follow-up of 25.2±11.1 months, primary patency was maintained in all cases. No death or amputation occurred; 2 patients had a myocardial infarction. Improvement in ABI was maintained (0.88±0.13) as well as Rutherford category. Conclusion: This study examined the use of the AFX unibody stent-graft for the treatment of TASC D AIOD with concomitant AAA. The AFX stent-graft appears to be a safe and effective solution for these complex lesions, with low morbidity and mortality.

Patency and Clinical Outcome After Stent Placement for Chronic Obstruction of the Inferior Vena Cava

The objective was to assess the technical success, patency, and clinical outcome after stent placement for chronic obstruction of the inferior vena cava (IVC). A retrospective analysis was carried out of patients with chronic IVC obstruction verified with computed tomography and/or magnetic resonance venography, accepted for stent placement at the Norwegian National Unit for Reconstructive Deep Venous Surgery from March 2010 to September 2015. Clinical status was categorized according to the CEAP classification and symptom severity was assessed using venous clinical severity score (VCSS). Stent patency was evaluated by colour duplex ultrasound. Large -diameter Wallstents were placed in the IVC and concurrent iliac and femoral obstructions via right internal jugular and femoral vein access. Sixteen patients presented with symptoms of chronic venous disease. Four patients had symptoms assumed to be related to a reduced cardiac preload. Twelve patients had IVC occlusion and eight had stenosis. Median follow-up was 25 months (range 3-70 months). Stent placement in the IVC was successful in 19 of 20 patients. Primary patency after 24 months was 67% and secondary patency 83%. Fifteen of 19 patients had open stents at final follow-up. Re-interventions were performed in four patients and included catheter directed thrombolysis in all and adjunctive stenting in three. Thirteen of 19 patients (68%) reported a sustained and significant clinical improvement. Mean VCSS improved from 8.5 (range 3-25) at baseline to 7 (range 2-23) at final follow-up (p=.007). There were no peri-procedural or long-term complications. The endovascular approach with stent placement for chronic IVC obstruction is a safe treatment option that should be offered to patients who otherwise have little opportunity for sustained clinical improvement.

Endovascular treatment for chronic lower extremity ischaemia with sub-acute deterioration.

The purpose of this study is to report the efficacy of endovascular treatment for patients with sub-acute (14-day to 2-month) deterioration of chronic lower extremity ischaemia. Between June 2013 and May 2015, 26 consecutive patients (22 men, 4 women; mean age, 68.6 years; range, 50-86 years) were treated for sub-acute deterioration of chronic lower extremity ischaemia in our hospital. All patients were treated with catheter-directed thrombolysis initially and then adjunctive percutaneous transluminal angioplasty and/or stenting was performed to correct underlying lesions. The 26 intra-arterial thrombolysis procedures were all performed in native lower arteries including 8 iliac, 13 femoropopliteal and 5 diffuse occlusions involving the iliac and femoropopliteal segments. Lesion length decreased from 194 mm (70-350 mm) to 92 mm (20-270 mm) after the thrombolytic procedures, and the residual lesions were corrected with percutaneous transluminal angioplasty alone in 4 (15.4%) limbs and stenting in 22 (84.6%) patients. No cross-joint stenting was seen in the 22 affected limbs that used stents. Throughout the treatment process, nine patients with intermittent claudication achieved an unrestricted walking distance, and 17 patients with rest pain or foot ulcers showed significant symptom improvement. The mean ankle-brachial index increased from 0.42 ± 0.16 preoperatively to 0.81 ± 0.25 postoperatively ( p < 0.01). Endovascular therapy with catheter-directed thrombolysis and percutaneous transluminal angioplasty/stenting is feasible for sub-acute deterioration of chronic lower extremity ischaemia patients with favourable midterm results.